MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-06-11 for UNIVERSAL COUCHTOP RECTANGULAR EXTENSION MTIL6600 manufactured by Medtec, Inc..
[17534288]
Prone patient climbed onto the couch with his head and shoulders over the extension. He was then asked to move and grabbed the sides of the extension with his hands lifting himself up slightly. The extension then came free of the main couch resulting in the patient falling to the floor and hitting himself upon the theraview imaging unit. The patient was described as large but not the largest. The patient appeared unharmed and continued treatment on a difference machine.
Patient Sequence No: 1, Text Type: D, B5
[17642045]
Results: locking mechanism. Method: distributor's description of events were reviewed. These observations described were able to be duplicated with product evaluated from inventory by mechanically distributing a load unevenly across the device. Results: clinicians did not follow instructions for using the device and allowed patients to reposition themselves without aid. Uneven loading and shifting on the device result in a force placed on the axel of the locking mechanism resulting in its rotating until it reaches the release point and the extension disengages. Conclusion: user error allowing patient to reposition unaided contributed to device failure. Remedial action initiated: notifications sent to customers identifying the potential failure method for the extension and providing reminders on how to utilize the product. New re-designed latches with positive locking feature are being sent out to all customers to replace the current latches on their extension units.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2010-00002 |
| MDR Report Key | 1725408 |
| Report Source | 01,08 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date of Event | 2010-05-21 |
| Date Mfgr Received | 2010-05-21 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2012-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1401 8TH ST. S.E. |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127378688 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL COUCHTOP RECTANGULAR EXTENSION |
| Generic Name | UNIVERSAL COUCHTOP RECTANGULAR EXTENSION |
| Product Code | IXQ |
| Date Received | 2010-06-11 |
| Model Number | MTIL6600 |
| Catalog Number | MTIL6600 |
| Lot Number | M161450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC. |
| Manufacturer Address | 1401 8TH ST. S.E. ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |